Kornimate/medical-research-clean huggingface dataset:
rapid diagnostic test for detection of group b streptococcus in pregnancy

Conditions: Streptococcus Infection; Pregnancy

Summary: this study evaluates the use of a new method of growing and detecting group b streptococcus in pregnant women. this new method utilizes sandwiched-membrane petri technology and has the advantage of detecting gbs in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

intrapartum infection with group b streptococci (gbs) may lead to untoward neonatal sequelae such as pneumonia, septicemia, and meningitis. several clinical trials have demonstrated that the use of intrapartum intravenous antibiotic prophylaxis (with penicillin being the agent of choice due to a narrower spectrum of antimicrobial activity) is highly effective to prevent early-onset neonatal gbs infections. it has been estimated that 10% to 30% of all pregnant women are gbs carriers, and it is likely that gbs colonizes virtually every female at some point. consensus guidelines from the centers for disease control and prevention (cdc), american college of obstetricians and gynecologists (acog), and the american academy of pediatrics, recommend prenatal screening at 35 to 37 weeks of gestation and chemoprophylaxis at delivery based upon this culture result. the cdc-recommended method for detecting gbs colonization involves collecting a combined vaginal and rectal specimen and culturing the organism in a selective broth medium, followed be subculturing onto blood agar plates. however, this traditional method of culture takes up to 72 hours for results to be available. with 12.8% of patients experiencing a preterm delivery prior to when a gbs screening occurs, and up to 15% of term pregnancies not having routine gbs screening performed, a significant portion of women present with unknown gbs status at the time of potential delivery. these clinical situations require obstetricians to utilize a risk-based strategy that has been shown to be only half as effective as culture-based screening. thus, a need exists for a rapid detection method for gbs. recent research has focused on polymerase chain reaction (pcr) based methods for detection of gbs. sensitivity for detection of gbs by the pcr assay has ranged from 87% to 91%. these methods are limited by high cost, and inability to perform antibiotic sensitivities for gbs (in women with a penicillin allergy). new technologies, called bionanopore (bnp) and bionanofilter (bnf) are rapid, microbial detection systems that utilizes sandwiched-membrane petri technology. these have the advantage of detecting gbs in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

Eligibility criteria:
inclusion criteria: * \> 18 years * 35-37 weeks pregnancy * patient receiving prenatal care at ut houston hermann memorial ob/gyn resident or attending clinic. exclusion criteria: * pt elects not to participate

Keywords: gbs, streptococcus, . group b
safety, tolerability, pharmacokinetics (pk), and activity of atyr1940 in participants with muscular dystrophy - study extension

Conditions: Facioscapulohumeral Muscular Dystrophy

Summary: the purpose of this study is to assess the safety and tolerability profile of atyr1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies.

the purpose of this study is to assess the safety and tolerability profile of atyr1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies, and to additionally explore the pharmacokinetics and biologic activity of atyr1940 in adult participants with molecularly defined genetic muscular dystrophies. participants who successfully complete the parent study (nct02239224) are eligible for enrollment into this long-term extension study.

Eligibility criteria:
inclusion criteria: * participant has an established, genetically-confirmed, diagnosis of facioscapulohumeral dystrophy with clinical findings meeting existing criteria. * participant is a male or female aged 18 to 65 years, inclusive. * participants who previously participated in study atyr1940-c-002 and who meet the entry criteria above for the current study will be eligible for enrollment. exclusion criteria: * participant is currently receiving treatment with an immunomodulatory agent or has a history of such treatment, including targeted biological therapies (for example, etanercept, omalizumab) within the 3 months before baseline; corticosteroids within 4 weeks before baseline; or non-steroidal anti-inflammatory agents (nsaids) within 2 weeks before baseline. * participant has a severe retinopathy. * participant has a history of obstructive or restrictive lung disease (including interstitial lung disease, pulmonary fibrosis, or asthma), or evidence for interstitial lung disease on screening chest radiograph. * participant has evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, dermatological, or gastrointestinal disease, or has a condition that requires immediate surgical intervention, other treatment or may not allow safe participation. * participant has used any investigational product or device (other than a mobility assistance device) within 30 days before baseline. * if female and of childbearing potential (premenopausal and not surgically sterile), participant has a positive pregnancy test at screening or is unwilling to use contraception from the time of screening through the 1-month follow-up visit. acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device. * if male, participant is unwilling to use a condom plus spermicide during sexual intercourse from the time of screening through the 1-month follow-up visit.
genetic predisposition to breast and ovarian cancer: prospective study of brcax gene mutation

Conditions: Breast Cancers; Ovarian Cancers

Summary: cohort of subjects carrying a brca gene mutation: genetic predispositions to breast and ovarian cancers

cohort of subjects carrying a brca gene mutation: genetic predispositions to breast and ovarian cancers

Eligibility criteria:
1. woman or man, with or without cancer, carrying a deleterious brca1/brca2 mutation, aged 18 years and over. 1. woman with or without breast cancer or ovarian cancer at baseline. 2. man with or without breast cancer at baseline. 2. signed consent to participation 3. affiliation to a social security regimen, or beneficiary of such a regimen. exclusion criteria: 1. a person of legal age subject to a legal protection measure, or unable to express consent. 2. impossibility to submit to the follow-up of the test for geographical, social or psychological reasons

Keywords: brca gene mutation
efficacy, safety, and tolerability study of sotagliflozin as adjunct therapy in adult patients with type 1 diabetes mellitus who have inadequate glycemic control with insulin therapy

Conditions: Type 1 Diabetes Mellitus

Summary: this phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin a1c (a1c) reduction at week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (t1d) who have inadequate glycemic control with insulin therapy.


Eligibility criteria:
inclusion criteria: * participants had given written informed consent to participate in the study in accordance with local regulations. * adult participants 18 years and older with a diagnosis of t1d made at least 1 year prior to informed consent. * participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (csii) or multiple daily injections (mdi). * willing and able to perform self-monitored blood glucose (smbg) and complete the study diary as required per protocol. * at the screening visit, a1c must be between 7.0% to 11.0%. * females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test . exclusion criteria: * use of antidiabetic agent other than insulin or insulin analog at the time of screening. * use of sodium-glucose cotransporter (sglt) inhibitors within 8 weeks prior to randomization. * chronic systemic corticosteroid use. * type 2 diabetes mellitus (t2d), or severely uncontrolled t1d as determined by the investigator.
human immune responses toward hiv-1 envelope antigens

Conditions: HIV Infection

Summary: the primary objectives of this study is to * define the envelope-specific b-cell and t-cell responses in humans who have received a st. jude hiv-1 vaccine. * describe mechanisms of hiv-1 envelope processing and consequent b-cell and t-cell activities.

the goal of this protocol is to understand how human lymphocytes respond to hiv-1 antigens in the context of vaccination or infection. this protocol will support understanding of the immune response by providing a source of lymphocytes and serum from selected individuals to study in laboratory based investigations. blood samples from individuals who have received an hiv-1 vaccine, individuals who are hiv-1-infected, and individuals who are hiv-1-uninfected are requested to: (1) test previously vaccinated volunteers for hiv-1 envelope-specific b-cell and t-cell immune activities, and (2) increase understanding of how the human immune system processes and responds to hiv-1 envelope proteins.

Eligibility criteria:
inclusion criteria: * participant is greater than or equal to 18 years of age. * participant is in good general health. * participant weighs ≥ 110 pounds. * participant has hemoglobin \> 12 gm/dl within last 12 weeks. group 1 (vaccinees) only inclusion criteria: * participant has previously received one of the st. jude hiv-1 vaccines via enrollment in prior st. jude hiv vaccine studies. group 2 (hiv positive) only inclusion criteria: * participant is hiv-1 positive by medical record review. group 3 (hiv negative) only inclusion criteria: * participant is hiv-1 negative as determined by hiv elisa. exclusion criteria: * participant is unable or unwilling to give written informed consent. * participant is pregnant female. group 2 (hiv positive) only exclusion criteria: * participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week)

Keywords: vaccine response human lymphocytes
tenaculum pain control study

Conditions: Cervical Pain; Pelvic Pain

Summary: the purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. this study will also evaluate how satisfied women are with the method of pain control used. the researchers hypothesize that: 1. there is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel. 2. patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.

subjects who have already scheduled an iud insertion or endometrial biopsy will be asked to join this study assessing two pain control interventions at the time of tenaculum application to the cervix during office gynecologic procedures. only healthy women ages 18 and over with an indication for endometrial biopsy or iud placement will be recruited. the participants will be randomized to one of two arms: an intracervical lidocaine injection versus topical lidocaine gel. they will be asked to indicate their level of pain and level of satisfaction using a visual analog scale. the primary outcome, pain with tenaculum placement, and the secondary outcome, satisfaction with the experience of tenaculum placement, will be compared between the study groups.

Eligibility criteria:
inclusion criteria: * generally healthy women * age 18 and over * indication for endometrial biopsy or iud placement exclusion criteria: * allergy to lidocaine or other local anesthetic * pregnancy, known or suspected * patients who are premedicated with misoprostol * patients with a chronic pain condition for which the patient takes daily pain medication

Keywords: tenaculum pain lidocaine
development and validation of (bio)sensors for the identification of pathogens

Conditions: Infections; Infection, Bacterial; Infection Viral; Infection, Parasite; SARS CoV 2 Infection; Pseudomonas Aeruginosa Infection; Leishmania Infantum Disease

Summary: the recent covid-19 pandemic has revealed the need to develop tests that are accurate, rapid, and inexpensive for the diagnosis of infectious diseases. this problem is relevant not only for viruses, but also for bacteria and parasites: the identification of pathogens at low concentrations by simple and accurate methods is still largely unsatisfied because these microorganisms are structurally complex and are incorporated in composite and diverse biological samples, which can create relevant interferences in pathogens' detection. direct diagnostic approaches, such as microscopic examination, culture and molecular testing are carried out in equipped laboratories and require long waiting times to obtain the results. recently developed point-of-care (poc) tests are a group of technologies that miniaturize tests into portable devices such that they can be performed both in well-equipped laboratories and outside the conventional laboratory setting. the present study aims to explore the feasibility and adaptability of newly developed platforms to detect: 1. a virus (sars-cov2), 2. a bacterium (pseudomonas aeruginosa) and 3. a protozoan parasite (leishmania infantum) in clinical specimens, such as blood and respiratory samples. these newly developed platforms are expected to overcome the current limitations of molecular testing (high cost, time required and need for well-equipped laboratories) and rapid testing (high number of false-negative results). in addition, the newly developed platforms may have important clinical application in low-income countries, which will benefit from a simple and inexpensive approach to detect the many infectious diseases that affect millions of people each year.


Eligibility criteria:
inclusion criteria: * obtaining informed consent * age ≥ 18 years * patients who meet one of the following conditions: sars-cov2 positive patients (group 1), sars-cov2 negative patients (group 2), p. aeruginosa positive patients (group 3), p. aeruginosa negative patients (group 4), l. infantum positive patients (group 5), l. infantum negative patients (group 6). exclusion criteria: * none

Keywords: infections platform nanobiotechnological platforms bacterial viral protozoan diagnostic point of care test
impact of personalized rehabilitation guidance

Conditions: Knee Osteoarthritis

Summary: to investigate the impact of personalized rehabilitation guidance based on the wechat official accounts platform on the functional recovery and quality of life of patients with knee osteoarthritis (koa).ninety patients diagnosed with koa undergoing joint replacement were included via convenient sampling.the patients were randomly divided into an observation group and a control group,with 45 patients in each group.the control group received traditional rehabilitation guidance,while the observation group received personalized rehabilitation guidance through the wechat official accounts platform in addition to the traditional guidance.different care plans had varying effects on patients' scores on the 36-item short form health survey (sf-36),visual analog scale (vas),and lysholm knee scoring scale.


Eligibility criteria:
inclusion criteria: * aged 50 to 80 years; * conscious, without cognitive impairments, and able to complete reading independently or with assistance; * able to operate a smartphone and use wechat; * willing to participate in this study and provide signed informed consent. exclusion criteria: * acute cerebrovascular disease with sequelae in the past 6 months; * coexisting primary psychiatric disorders; * unable to perform physical exercise due to physical disability in the lower limbs; * postoperative complications, such as deep vein thrombosis or infection; * participation in other interventional studies.
monogenic lupus in childhood onset systemic lupus erythematosus

Conditions: Monogenic Lupus; Systemic Lupus Erythematosus

Summary: the purpose of this study is to unravel the proportion of monogenic lupus in children onset systemic lupus erythematosus (sle), and to find out the diagnostic strategy for early detection of monogenic lupus.

childhood systemic lupus erythematosus (sle) is a common autoimmune disease in children, with a high incidence in asia. compared with adult sle, childhood sle is more likely to involve multiple systems, the treatment is more difficult, and mortality is relatively high. with the improvement of diagnosis and treatment of sle, the prognosis of children with sle continues to improve, but there are still a small number of patients who are ineffective to existing treatments. the pathogenesis of sle is complicated, and more and more evidences confirm that genetic factors are involved in the pathogenesis of sle. in recent years, the concept of "monogenic lupus" has been proposed internationally, and more than 30 single gene variants have been found to be related to the onset of sle. such patients are clinically in line with typical sle or lupus-like syndrome, with common characteristics of a very young age of onset (mostly in infants and young children), and/or a family history of rheumatic immune diseases. it is a huge difficulty to early identify these patients at present, and it has not been generally accepted in the field of rheumatology in china. in this research, about 200 patients with childhood onset sle that meet the criteria for inclusion and exclusion were tested for gene analysis, and clinical data were collected and entered into the sle cohort database. the incidence of monogenic lupus in childhood onset sle will be unraveled. based on clinical key words, such as early onset, male, family history of rheumatic diseases, blood system involvement, kidney involvement, the incidence of monogenic lupus in these single or multiple keyword combination will be calculated and compared to obtain an early, cost-effective diagnosis strategy for monogenic lupus.

Eligibility criteria:
inclusion criteria: subjects who meet the following criteria will be allowed to participate in the study: 1. onset age: birth to 18 years; 2. meet the diagnostic criteria of sle according to acr(1997), or slicc(2012), or eular/acr (2019); 3. obtain parental consent. exclusion criteria: 1. lack of clinical data; 2. unable to finish the follow-up.
an observational study of the safety of direct-acting antivirals in patients with hepatitis c

Conditions: Hepatitis C, Chronic

Summary: the investigators will assess whether patients with the hepatitis c virus (hcv) who are prescribed direct-acting antiviral (daa) medications experience higher rates of adverse events than patients with hcv who are untreated. the investigators hypothesize that patients receiving daas do not experience higher rates of adverse events compared to patients who have not received daas. the study population is adults between the ages of 18 and 88 with any indication of a diagnosis of hcv. an intervention group (those receiving a daa) and comparison group (those who are not treated) will be created using medication dispensing data. eligibility for the study will be determined from january 1, 2011 through december 31, 2017. covariates will be collected from january 1, 2011 through december 31, 2017. individual study sites may have access to historical data prior to 2011 that can be used as covariates or to identify individuals with hcv. the primary outcomes of interest include acute myocardial infarction, neurological outcomes (e.g. acute stroke, intracranial bleed), acute kidney failure, acute on chronic liver failure, hepatic decompensation, multiple organ dysfunction syndrome, cancer, bradyarrhythmia, and death. the secondary outcomes include decompensated cirrhosis, hospitalization, emergency department visit, and arrhythmia. outcomes will be assessed from january 1, 2011 through december 31, 2017. the investigators will use two different analytic approaches to answer the question of interest: a poisson regression model and marginal structural modeling (msm). the simpler poisson model is an extension of tabular rate of event analysis. the more complicated msm model incorporates modeling of the treatment decision to more flexibly control for confounding by indication. for each outcome, the investigators will only record the first date an outcome occurs. each outcome will be modeled separately.


Eligibility criteria:
inclusion criteria: * hcv viral load * hcv genotype * hcv qualitative * hcv antibody * hcv drug * continuously enrolled 12 months exclusion criteria: * each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome. the results will be examined for sensitivity to the following possible exclusion criteria: * achieved svr-12 prior to index date * hcv treatment experienced prior to index date * no visit in gi, infectious disease, or liver transplant / hepatology * no positive hcv test (genotype, viral load, or qualitative) * no recent positive hcv test (genotype, viral load or qualitative)

Keywords: drug-related side effects and adverse reactions antiviral agents / adverse effects antiviral agents / toxicity simeprevir sofosbuvir ledipasvir ombitasvir paritaprevir ritonavir dasabuvir daclatasvir elbasvir grazoprevir velpatasvir ribavirin
nasal administration of sufentanil+ketamine for procedure-related pain in children

Conditions: Pain

Summary: the aim of the study is to investigate the absorption and clinical effect of nasal administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to medical procedures in hospitalized children.

the management of procedural pain in children ranges from physical restraint to pharmacological interventions. pediatric formulations that permit accurate dosing, are accepted by children and a have a rapid onset of analgesia are lacking. the objectives were to investigate a pediatric formulation of intranasal sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg for procedural pain and to characterize the pharmacokinetic (pk) profile. fifty children (≥10 kg) scheduled for a painful procedure were included in this prospective nonrandomized open-label clinical trial. thirteen of these children had central venous access for drug assay sampling; enabling a compartmental pk analysis using nonlinear mixed-effects models. pain intensity before and during the procedure was measured using age-appropriate pain scales. heart rate, oxygen saturation and sedation were recorded.

Eligibility criteria:
inclusion criteria: * children and adolescents treated at the university hospital, rigshospital * painful medical procedure related to the patients treatment * patient and/or the parents must be able to understand and speak danish * negative pregnancy test for girls, when relevant * signed informed consent * only a light meals or no meals have been ingested 2 hours prior to inclusion exclusion criteria: * allergy to sufentanil or ketamine * abnormal nasal cavity * have been treated with sufentanil and/or ketamine during the last 48 hours * nasal obstruction (rhinitis)

Keywords: painful medical procedures